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- PMLiVE

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- PMLiVE

Biosimilar Lantus leads CHMP opinions

Boehringer and Lilly’s insulin one of six new medicines recommended for EU approval

- PMLiVE

Avastin first biologic backed in EU for resistant ovarian cancer

Roche drug recommended in latest round of CHMP opinions

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Updated EMA reports better suited to HTA needs

Changes to drug licensing reports are helping to support reimbursement decisions

- PMLiVE

EMA gives December deadline for information updates

Pharma companies must revise their medicines information by year-end

- PMLiVE

ADA: Empagliflozin overcomes FDA concerns

Boehringer and Lilly expect decision on diabetes treatment by end of 2014

- PMLiVE

EMA: We will allow clinical data download

Regulator says it hasn't watered down trial transparency measures

- PMLiVE

EMA adaptive licensing project gathers pace

Regulator picks two drugs to pilot early access scheme

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EC approves drugs for diabetes and Crohn’s disease

Takeda’s Entyvio and Boehringer/Lilly’s Jardiance get green light

Roche - Basel

CHMP turns down Avastin for brain cancer

Roche set to be denied expanded use for oncology drug in Europe

- PMLiVE

CHMP backs European approval for six new medicines

Recommends drugs by PTC Therapeutics, Roche, Biogen Idec, Octapharma, Alcon and Veloxis Pharma

- PMLiVE

Teva backs laquinimod for MS despite CHMP rejection

EMA confirms negative opinion after re-examination

- PMLiVE

FDA clears Takeda’s vedolizumab for inflammatory bowel disease

Entyvio licensed for patients who have not responded to current therapies

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